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Stelara Approved to Treat Moderate to Severe Plaque Psoriasis in Adults

Stelara Approved to Treat Moderate to Severe Plaque Psoriasis in Adults 1

(intended to achieve exposures comparable to adults) or STELARA half standard dosing (intended to achieve exposures half of those seen in adults) at weeks 0 and 4 followed by every 12 week dosing. STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A (PUVA). Food and Drug Administration today approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis. Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance, said Julie Beitz, M. Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body s own antibodies that are produced as part of the immune system.

Stelara Approved to Treat Moderate to Severe Plaque Psoriasis in Adults 2The purpose of this study was to evaluate ustekinumab in patients age 12 to 17 years who had moderate-to-severe psoriasis. Cosentyx is the first fully human interleukin-17A inhibitor approved for adults to treat moderate-to-severe plaque psoriasis, and was recently approved for the treatment of psoriatic arthritis and ankylosing spondylitis in the EU and US. Many agents used in the treatment of adult psoriasis have also been used for children 16. While both the excimer laser and narrow band UVB are approved for use in psoriasis, inconsistencies in third party coverage for these treatments limit their utilization. In addition, ustekinumab (45 or 90 mg dose) and adalimumab yielded significantly higher PASI 75 rates than etanercept (25 or 50 mg dose).

Ustekinumab injection is used to treat moderate-to-severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. For apremilast (Otezla) and for ustekinumab (Stelara), member is 18 years of age or older. The assessment found that the general efficacy of adalimumab, alefacept, etanercept, infliximab, and ustekinumab for the treatment of moderate to severe plaque psoriasis was supported by multiple good to fair randomized controlled trials. The FDA approved apremilast (Otezla) to treat adults with active psoriatic arthritis. Health Canada has approved Stelara for treating moderate-to-severe plaque psoriasis in adolescents who are intolerant to or have been inadequately controlled by other systemic therapies or phototherapies, according to a press release from Janssen. Ustekinumab, delivered by subcutaneous injection, was approved in Canada for treating adults with psoriasis in 2008, according to the release.

Ustekinumab In Adolescent Patients Age 12 To With Moderate-to-severe Plaque Psoriasis: Results Of The Randomized Phase 3 Cadmus Study

Cosentyx is the first fully human interleukin-17A inhibitor approved for adults to treat moderate-to-severe plaque psoriasis, and was also recently approved for the treatment of psoriatic arthritis and ankylosing spondylitis in Europe. Treating plaque psoriasis can be challenging. Ask about STELARA and how it works differently to treat moderate or severe plaque psoriasis. Stelara is used in adults to treat plaque psoriasis or psoriatic arthritis. For use in the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy: 100 kg (220 lbs) or less: Initial dose: 45 mg subcutaneously once initially and 4 weeks later Maintenance dose: 45 mg subcutaneously once every 12 weeks Greater than 100 kg (220 lbs): Initial dose: 90 mg subcutaneously once initially and 4 weeks later Maintenance dose: 90 mg subcutaneously once every 12 weeks In subjects weighing greater than 100 kg, 45 mg was also shown to be effective.

Ustekinumab (by Injection)